Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis

A Study of Quality of Life and Changes to Symptom Relief for Acute Uncomplicated Cystitis Treated With Antibiotics (Ciprobay); Prospective, Open-label, Multicenter, Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01631955

Enrollment

386

Registered

2012-06-29

Start date

2009-10-31

Completion date

2011-10-31

Last updated

2012-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cystitis

Keywords

Acute cystitis, Antibiotics, Quality of life

Brief summary

Although Cystitis includes a clinical syndrome characterized by various combinations of dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been little research on Clinical aspects on cystitis treatment such as bothersomeness, or the impact of symptoms on patients' quality of life (QoL). The investigators want to study for Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay) in Acute Uncomplicated Cystitis in Korean Women.

Interventions

DRUGCiprobay

Ciprobay (250mg, bid, oral)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Female outpatients (20-65 years old) * Acute cystitis symptoms (subject-reported) for \< 1 week prior to Visit 1.

Exclusion criteria

* Acute cystitis symptoms for ≥ 1 week prior to Visit 1. * Diabetes mellitus * Congenital urinary tract abnormality * Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study. * Hypersensitivity to the active substance (Ciprobay). * Subjects who have vaginal discharge * Fever ( ≥ 37.5 ºC) * Sexually transmitted diseases. * Documented significant renal disease (sCr \> 1.5) * Subjects who cannot consent to this study. * Subjects who had received antimicrobial agents in the previous 4 weeks. * Recurrent urinary tract infection defined as treatment for UTI \> 3 times in the last year. * Use of an indwelling catheter or an intermittent self-catheterization program. * Neurogenic bladder.

Design outcomes

Primary

Measure	Time frame
Effect on patient satisfaction and quality of life.	at day 5 relative to baseline

Secondary

Measure	Time frame
Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria)	at day 10, 21 and 28 relative to baseline
Change in KHQ	at day 10, 21 and 28 relative to baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026